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Apremilast

Otezla

Extended indication

Extension of indication to include the treatment of moderate to severe chronic plaque psoriasis in c

Therapeutic value

No estimate possible yet
Registration phase

Registration application pending

Product

Active substance

Apremilast
Domain

Chronic immune diseases
Reason of inclusion

Indication extension
Main indication

Other chronic immune diseases
Extended indication

Extension of indication to include the treatment of moderate to severe chronic plaque psoriasis in children and adolescents from the age of 6 years who have a contraindication, have an inadequate response, or are intolerant to at least one other systemic therapy or phototherap
Proprietary name

Otezla
Manufacturer

Amgen
Mechanism of action

Enzyme inhibitor
Route of administration

Oral
Therapeutical formulation

Tablet
Budgetting framework

Intermural (MSZ)
Centre of expertise

ErasmusMC, AMC/VUMC/READE
Additional remarks 
PDE4-inhibitor

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

December 2023
Expected Registration

September 2024
Orphan drug

Yes
Registration phase

Registration application pending
Additional remarks 
NCT04175613

Therapeutic value

Therapeutic value

No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.